A quantitative method for assessing treatment-related changes within the airway mucosa in patients with chronic bronchitis.

Background: No standardized method has yet been established for evaluating airway mucosal aberrancies associated with chronic obstructive pulmonary disease (COPD) or chronic bronchitis (CB). While goblet cell hyperplasia (GCH) is an established pathognomonic hallmark of the CB disease process, no standardized method exists for acquiring mucosal biopsies and assessing morphologic airway mucosa alterations. Additionally, the impacts from interventions targeting the airway mucosa are not well defined. In this context, a reliable and robust measure for assessing airway mucosa at baseline and subsequent to an intervention is critical for characterizing treatment-related changes.
Research Question: Can standardizing airway biopsy tissue collection and histopathological assessment methods generate a robust and repeatable measure to assess airway mucosa tissue characteristics in the setting of COPD/CB?
Study Design & Methods: Initial tissue collection and histological assessment methods were designed by integrating various aspects from previously published evaluations, applied to an initial tissue sample cohort, and then iteratively refined by independent pathologists.
Results: A standardized metric for histologic airway mucosa assessments was developed that specified tissue collection methods, including re-sampling airways at multiple time points to enable evaluation of treatment-related effects by incorporating scores for GCH, eosinophilia, and chronic inflammation, and the degree of GCH heterogeneity present within each sample.
Conclusion: This multi-center study generated a robust, reproducible approach for assessing airway mucosa aberrancies in the setting of COPD/CB. The iterative approach established consistent tissue specimen recovery and a granular scoring matrix that enabled quantitative scoring of the various tissue findings with substantial histopathologic interrater reliability.
Clinical Trial Registration Number: ClinicalTrials.gov; NCT03107494, NCT04677465; URL: www.
Clinicaltrials: gov. Australian New Zealand Clinical Trials Registry (ANZCTR); ACTRN12617000330347; URL: anzctr.org.au.
Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:William Krimsky reports a relationship with Galvanize Therapeutics Inc that includes: employment and equity or stocks. Paul VanderLaan reports a relationship with Galvanize Therapeutics Inc that includes: consulting or advisory. Paul VanderLaan reports a relationship with Intuitive Surgical Inc that includes: consulting or advisory. Paul VanderLaan reports a relationship with Ruby Robotics that includes: consulting or advisory. Paul VanderLaan reports a relationship with Agilent Technologies that includes: consulting or advisory. Paul VanderLaan reports a relationship with Veracyte Inc that includes: consulting or advisory. Jeffrey Iding reports a relationship with Galvanize Therapeutics Inc that includes: consulting or advisory. David Hunter reports a relationship with Galvanize Therapeutics Inc that includes: employment and equity or stocks. Beryl Hatton reports a relationship with Galvanize Therapeutics Inc that includes: employment and equity or stocks. Brett Bannan reports a relationship with Galvanize Therapeutics Inc that includes: employment and equity or stocks. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)